ACON LABORATORIES, INC.

Address:5850 Oberlin Drive, # 340,SAN DIEGO,CA,92121,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

GLUCOSE OXIDASE, GLUCOSE (CGA) (7) SYSTEM, HEMOGLOBIN, AUTOMATED (GKR) (3)

Premarket Exempt

No Yes

Clear

On Call Vivid Blood Glucose Test Strips - 00682607000029 Catalog Number :

Device Description : Blood Glucose Test Strips, vial of 10 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 10

On Call Vivid Blood Glucose Test Strips - 00682607000036 Catalog Number :

Device Description : Blood Glucose Test Strips, vial of 50 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

On Call Express Blood Glucose Test Strips (10ct) - 00682607000081 Catalog Number :

Device Description : Blood Glucose Test Strips, vial of 10 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 10

On Call Express Blood Glucose Test Strips - 00682607000098 Catalog Number :

Device Description : Blood Glucose Test Strips, vial of 50 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

On Call Plus Blood Glucose Test Strips - 00682607000142 Catalog Number :

Device Description : Blood Glucose Test Strips, vial of 10 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 10

On Call Plus Blood Glucose Test Strips - 00682607000159 Catalog Number :

Device Description : Blood Glucose Test Strips, vial of 50 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 50

Mission Plus Hemoglobin (Hb) Test Cartridges - 00682607000197 Catalog Number :

Device Description : Vial of 10 Test Cartridges

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 10

Mission Plus Hemoglobin (Hb) Optical Verifier - 00682607000203 Catalog Number :

Device Description : Vial of 2 Optical Verifiers

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 2

Mission Capillary Transfer Tubes - 00682607000227 Catalog Number :

Device Description : Bag of 25 capillary transfer tubes (25/bag)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 25

On Call Pro Blood Glucose Test Strips - 00682607000296 Catalog Number :

Device Description : Blood Glucose Test Strips, vial of 50 strips

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 50

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